POSTED AUGUST 12, 2020
In this introductory video, medical device regulatory affairs expert and former FDA staffer David Pudwill introduces his Mr. Regulatory "FDA Guidance Review" series, in which he offers seasoned perspective, tips, and advice to the global medtech regulatory community about impactful new medical device guidance documents and other announcements coming out of the U.S. Food & Drug Administration.
With each twice-weekly episode, stay on top of FDA's evolving policies, and learn how to engage effectively with the agency - both are critical to the success of your medical device regulatory strategy.
POSTED AUGUST 13, 2020
What steps do medical device manufacturers need to take if they have to notify FDA and consignees about a product recall, and what specific information is used to evaluate the recall? In this episode, David overviews the March 2020 Guidance Document: “Product Recalls, Including Removals and Corrections.”
POSTED AUGUST 21, 2020
FDA has updated Guidance specifying how it will implement uniform processes and standards that are applicable to inspections of foreign and domestic device establishments. In this episode, David discusses the June 2020 Guidance Document: “Review and Update of Device Establishment Inspection Processes and Standards.”
POSTED AUGUST 25, 2020
FDA has issued an immediately-in-effect Guidance on its policy regarding unique device identification (UDI) and other compliance dates for class I and unclassified devices that are not implantable, life-supporting, or life-sustaining. In this episode, David details this July 2020 Guidance Document: “Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking.”
POSTED SEPTEMBER 10, 2020
Section 745A(b)(3)(A) of the FD&C Act authorizes FDA to specify in Guidance that specific medical device submissions are required to be submitted solely in electronic format, as the agency is committed to helping improve submission review process consistency and efficiency. In this episode, David discusses and provides insightful tips and advice related to the July 2020 Guidance Document: “Providing Regulatory Submissions for Medical Devices in Electronic Format - Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act.”
POSTED SEPTEMBER 17, 2020
A recently issued Guidance explains FDA’s regulatory approach and policy for all device products with at least one FDA-regulated device function and at least one “other function.” In this episode, David discusses and provides insightful tips and advice related to the comprehensive July 2020 Guidance document, “Multiple Function Device Products: Policy and Considerations.”
POSTED SEPTEMBER 22, 2020
FDA has issued new draft Guidance in which the Agency outlines recommended best practices for developing relevant, reliable, and sufficiently robust patient-reported outcome (PRO) instruments for use in medical device evaluation, using the least burdensome approach. In this episode, David discusses and provides insightful tips and advice related to FDA’s August 31, 2020 Guidance document, “Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation.”
POSTED SEPTEMBER 25, 2020
FDA has issued guidance describing the procedures that the agency follows, and the actions that it may take during its review and evaluation of requests for recognition of a voluntary consensus standard for medical products, or the withdrawal of recognition. In this episode, David walks viewers through FDA’s September 15, 2020 Final Guidance document, “Recognition and Withdrawal of Voluntary Consensus Standards.”
POSTED OCTOBER 1, 2020
On September 25, 2020, the FDA issued final guidance that outlines details of the Accreditation Scheme for Conformity Assessment (ASCA) Pilot program, intended to increase confidence in testing results from ASCA-accredited testing laboratories, and potentially decrease the burden of premarket submissions when manufacturers rely on testing completed by ASCA-accredited testing laboratories. In this episode, David discusses FDA’s final guidance document, "The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program."
POSTED OCTOBER 21, 2020
In this episode, David overviews FDA’s guidance document, “Nonbinding Feedback After Certain FDA Inspections of Device Establishments,” published in April 2020, also highlighting comments provided in the docket and referencing the draft document issued in February 2019.
POSTED OCTOBER 23, 2020
FDA has posted draft guidance to propose select updates to its current thinking regarding the type of biocompatibility information that should be provided in a premarket submission for certain devices made from common polymers and fabrics that are in contact with intact skin. In this episode, David overviews this draft guidance document, “Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin,” published in October 2020.
POSTED OCTOBER 30, 2020
FDA has issued guidance to provide the agency’s current thinking on technical considerations specific to medical devices that have at least one patient-contacting component comprised of nitinol. In this episode, David overviews and provides insightful tips and advice on this final guidance document, “Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol,” published in October 2020.
POSTED NOVEMBER 11, 2020
The most widely used of all FDA premarket approval submission methods is the 510(k) clearance pathway. In this episode, David, with experience in reviewing hundreds of 510(k) submissions, overviews and provides insightful tips and advice on this comprehensive final guidance document, “Refuse to Accept Policy for 510(k)s,” published in September 2019.
POSTED NOVEMBER 16, 2020
In this episode, David overviews and provides insightful tips and advice on this final FDA guidance document, “Acceptance Review for De Novo Classification Requests,” published in September 2019.
POSTED NOVEMBER 21, 2020
In this episode, David overviews and provides insightful tips and advice on this final FDA guidance document, “Acceptance and Filing Reviews for Premarket Approval Applications (PMAs),” published in December 2019.
POSTED NOVEMBER 30, 2020
In this episode, David overviews and provides insightful tips and advice on this final FDA guidance document, “De Novo Classification Process (Evaluation of Automatic Class III Designation),” published in October 2017. Mr. Regulatory EPISODE 3, covering FDA's guidance on "Effects of COVID-19 on Formal Meetings/User Fee Applications for Medical Devices," is also referenced in this video.
Each week, David Pudwill releases insightful, timely new episodes in the FDA Guidance Review Video Series - watch them all on YouTube, and make sure to SUBSCRIBE to his channel!
The views and opinions expressed on this site and in all videos are those of the authors, speakers, and guests, and do not necessarily reflect the official policy or position of any company, FDA, or any other entity.